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Completed

NCT Number: NCT02196051

Basic Research Study to Examine the Relation Between Muscle Insulin Resistance and Lipid Production in the Liver.

The purpose of this study was to examine the pathophysiology of insulin resistance and the relation to the metabolic syndrome in humans.

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Key information

Conditions

Insulin Resistance Behavior Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Liver Diseases Metabolic Diseases Motor Activity Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YCCI/YNNH Hospital Research Unit

New Haven, Connecticut, 06520, United States

About this study

In this study insulin resistant (IR), young offspring of parents with type 2 diabetes (18-46 years) and healthy, lean elderly individuals (65-90 years) underwent 1H/13C MRS measurements of liver and muscle lipid and glycogen content before and after a high carbohydrate meal challenge. Hepatic de novo lipogenesis was determined as the incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5. These metabolic studies were performed in 2 sets: Study Part 1: Resting, Study Part 2: After 1 bout of 45 minutes exercise.

The study has been completed and published as two papers: August 16, 2011 and July 24, 2012.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index < 29 kg/m2
  • No regular exercise routine
  • Non-smokers
  • Absence of systemic and organ disease.

Exclusion criteria

  • Hematocrit < 35 vol%
  • History of claustrophobia
  • Ferromagnetic implants
  • Regular exercise regimen
  • Not weight stable
  • Any significant hematological, neurological, musculoskeletal or endocrine disease (including diabetes mellitus)
  • Any significant cardiovascular condition, including confirmed CAD and prior cardiovascular events
  • Taking coumadin as anticoagulant therapy.

Treatment and study plan

one bout of 45 minutes exercise

Other

45 minutes of exercise on an elliptical exercise machine

Primary outcomes

  1. change in de novo lipogenesis

    Time frame: Baseline

    At the baseline assessment, de novo lipogenesis was assessed after a high carbohydrate meal and a drink of heavy water. Muscle glycogen and lipid contents were measured pre- and post meal using 1H/13C MRS and de novo lipogenesis was assessed from the heavy water incorporation into blood lipid in samples collected overnight.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Lipid and Carbohydrate Metabolism: Effects of Exercise

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 21, 2014
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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